Green Light for New Drug

The annual infusion therapy Lemtrada moves closer to approval.

Lemtrada (alemtuzumuab) has received a positive indication from the Committee for Medicinal Products for Human Use (CHMP), an assessment body of the European Medicines Agency (EMA). The positive indication means that it has been recommended to the EMA for them to grant a marketing license to the makers, Genzyme. CHMP has recommended approval of the drug for those with relapsing-remitting MS. Lemtrada is an annual infusion therapy. It is administered in the first year over five consecutive days by intravenous infusion and then over three days one year later. For many people no further treatment is needed. In clinical trials people were found to experience half the number of relapsed as those on Rebif. Significant side effects include overactive or underactive thyroid and ITP, a blood clotting disorder. The EMA will now consider the CHMPs recommendation and is expected to make an announcement within three months. The drug will then be considered by the Irish Medicines Board (IMB) and the National Centre of Pharmacoeconomics (NCPE). The body will assess the cost-benefit of the drug and make a recommendation to the HSE on whether to reimburse the therapy or not. In recent years this process has been besieged by delays and issues with funding. Further reading:The CHMP recommendation News from GenzymeRead more about Lemtrada from the MS Trust, UK